Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:
- The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
- Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
- AMX0035 is currently under review with the European Medicines Agency
- 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!
POSITION SUMMARY
Amylyx is seeking a Lead, Clinical Pharmacology to lead neurology programs in early and late stages of clinical development - contributing to the design, planning, conduct, data analysis, interpretation, and reporting of Clinical Pharmacology studies. Reporting to the Head, Clinical Pharmacology and working closely with colleagues across research and development, the Clinical Pharmacology Lead applies their technical expertise to analyze, develop, validate, and implement quantitative models to inform key drug development decisions, and to make data-driven decisions based on pre-clinical and clinical information. You should be familiar with current practices in most of the following areas: clinical pharmacology, regulatory affairs, DMPK, translational sciences, bioanalytical method development and validation, and pharmacometrics. This is a remote based position; the individual can live in the US, Europe, or Canada.
RESPONSIBILITIES
- Overseeing clinical pharmacology studies on multidisciplinary program teams and working closely with clinicians, biostatisticians, translational scientists, medical writing, regulatory, and clinical operations colleagues to design, conduct and report clinical pharmacology trials including first-in-human, proof-of-concept, food effect (oral administration), drug-drug interaction, TQT, and special populations
- Conducting quantitative pharmacology analyses including NCA, population PK, exposure/response, and PBPK to streamline drug development and guide critical decisions including dose selection within the target patient population including sub-populations
- Collaborating with toxicologists and other non-clinical scientists to analyze translational models developed from preclinical data and to gain confidence in predicting human PK, efficacious doses, and dosage regimens
- Leading the design and development of Clinical Pharmacology submission documents for regulatory filings, managing responses and leading resolutions to health authority clinical pharmacology queries and requests, and representing Clinical Pharmacology in regulatory interactions
- Managing CROs assigned to conducting both pre-clinical and clinical pharmacology studies
- Assisting with study design and interpretation of nonclinical pharmacology and toxicology studies including application of translational methods
- Reviewing and providing inputs on the bioanalytical assay and validation report
- Collaborating cross-functionally with other departments, such as Biostatistics, Global Medical Affairs, Scientific Communications, CMC, Clinical, Toxicology, Pharmacovigilance and Regulatory Affairs
REQUIREMENTS
- PhD, MD, or PharmD in pharmacometrics, pharmaceutical sciences, or a related field
- Minimum 3 years of bio/pharmaceutical experience in Clinical Pharmacology and Pharmacometrics
- Proficiency with clinical pharmacology software and other computational tools (WinNonlin, NONMEM, etc.)
- An established track record of scientific project management, working in cross-functional teams, and an ability to lead multiple initiatives in a dynamic and fast paced environment
- Hands on experiences drafting clinical pharmacology documents (protocols, CSRs, etc.), reviewing statistical analysis plans (SAPs), and clinical pharmacology sections of regulatory submission documents (IBs, INDs, NDAs, briefing books, etc.)
- Strong communication and time/project management skills
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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
